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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSynchroMed II Motor Gear Train Shafts
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS261
Date Received10/28/2016
Decision Date04/03/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design and associated manufacturing process changes for the Motor Gear Train Shafts of the SynchroMed II implantable infusion pump. The design change involves applying a thin layer (~1.5?m) of DLC coating, to the three jewel interfacing shafts of the SynchroMed II motor to reduce the sensitivity of the interface to loss of lubrication.
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